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| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00794521 |
Purpose
RATIONALE: Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pazopanib is more effective than a placebo in treating patients with soft tissue sarcoma.
PURPOSE: This randomized phase III trial is studying pazopanib to see how well it works compared with a placebo in treating patients with metastatic soft tissue sarcoma that has relapsed or not responded to treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer Kidney Cancer Metastatic Cancer Ovarian Cancer Peripheral Nervous System Neoplasm Sarcoma Small Intestine Cancer |
Drug: pazopanib hydrochloride Other: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Official Title: | A Randomized Double Blind Phase III Trial of Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy. |
| Estimated Enrollment: | 360 |
| Study Start Date: | October 2008 |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
Patients receive oral pazopanib hydrochloride once daily for 28 days. Courses repeat every 28 days until disease progression or unacceptable toxicity.
|
Drug: pazopanib hydrochloride
Given orally
|
|
Arm II: Placebo Comparator
Patients receive oral placebo once daily for 28 days. Courses repeat every 28 days until disease progression or unacceptable toxicity.
|
Other: placebo
Given orally
|
OBJECTIVES:
Primary
OUTLINE: This is a multicenter study. Patients are stratified according to the number of prior chemotherapy regimens for advanced disease (1 vs 2 or more), and WHO performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.
After completion of study therapy, patients are followed every 8 weeks until disease progression and then every 3 months thereafter.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed high- or intermediate-grade* malignant soft tissue sarcoma, including any of the following subtypes:
Measurable disease
Disease progression by RECIST confirmed by radiological evaluation when compared to a disease assessment done within the past 6 months
No more than 4 lines* of prior systemic therapy for advanced disease and meeting the following criteria:
Metastatic disease
The following tumor types are not allowed:
PATIENT CHARACTERISTICS:
Cardiac function clinically normal by 12 lead ECG and no history of any cardiovascular conditions within the past 6 months including any of the following:
No poorly controlled hypertension (i.e., BP > 150/90 mm Hg)
Any of the following conditions are not allowed:
Deep venous thrombosis (DVT) or a pulmonary embolism in the past 6 months
No history of clinically significant gastrointestinal disorders including any of the following:
No hemoptysis within the past 6 weeks
PRIOR CONCURRENT THERAPY:
More than 14 days since prior and no concurrent substrates for the CYP450 enzymes, including any of the following:
No prior inhibitors of angiogenesis and/or VEGF- or VEGFR-targeting agents
Contacts and Locations| Netherlands | |
| European Organization for Research and Treatment of Cancer | Recruiting |
| Nijmegen, Netherlands, NL-6500 HB | |
| Contact: Winette T. A. Van der Graaf, MD, PhD 31-24-361-0353 | |
| Principal Investigator: | Winette T. A. Van der Graaf, MD, PhD | Universitair Medisch Centrum St. Radboud - Nijmegen |
More Information
| Study ID Numbers: | CDR0000624542, EORTC-62072, EU-20887, GSK-VEG110727, EUDRACT-2008-001307-33 |
| Study First Received: | November 19, 2008 |
| Last Updated: | November 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00794521 History of Changes |
| Health Authority: | Unspecified |
|
adult alveolar soft-part sarcoma adult angiosarcoma adult desmoplastic small round cell tumor adult epithelioid sarcoma adult fibrosarcoma adult leiomyosarcoma adult malignant fibrous histiocytoma adult malignant hemangiopericytoma adult malignant mesenchymoma adult neurofibrosarcoma adult rhabdomyosarcoma stage IV adult soft tissue sarcoma recurrent adult soft tissue sarcoma adult synovial sarcoma clear cell sarcoma of the kidney |
recurrent renal cell cancer stage IV renal cell cancer peripheral nervous system neoplasm recurrent uterine sarcoma stage IV uterine sarcoma uterine carcinosarcoma uterine leiomyosarcoma ovarian sarcoma endometrial stromal sarcoma small intestine leiomyosarcoma soft tissue metastases ovarian carcinosarcoma recurrent ovarian epithelial cancer stage IV ovarian epithelial cancer |
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Gastrointestinal Diseases Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Urologic Neoplasms Ileal Diseases Genital Diseases, Female Duodenal Neoplasms Neoplasms, Connective and Soft Tissue Endometrial Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Neuromuscular Diseases Ileal Neoplasms |
Urologic Diseases Jejunal Diseases Kidney Neoplasms Neoplasm Metastasis Uterine Neoplasms Kidney Diseases Duodenal Diseases Nervous System Neoplasms Endocrine Gland Neoplasms Jejunal Neoplasms Digestive System Neoplasms Ovarian Neoplasms Neoplasms by Histologic Type Nervous System Diseases Genital Neoplasms, Female |